Relapsed and Refractory Multiple Myeloma (RRMM)
Conditions
Keywords
RRMM
Brief summary
To investigate the safety and efficacy in patients with relapsed and refractory multiple myeloma treated with elranatamab under the actual use.
Detailed description
The objective of this study is to assess the safety and efficacy in patients with relapsed and refractory multiple myeloma (RRMM) treated with elranatamab under the actual use. * Primary objective: Confirm whether the onset status (the number of patients, incidence, grade, seriousness, timing of onset, duration, treatment and outcome) of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) is comparable to that in the clinical studies and whether adverse reactions were appropriately treated. * Secondary objective: Confirm the onset status of any adverse reaction (including unknown adverse reaction) to long-term treatment with elranatamab and the overall response (ORR) as efficacy assessment and evaluate them in terms of benefit-risk. Conditions for approval; Because of the extremely limited number of patients treated in Japanese clinical studies, a drug use investigation in all patients should be conducted to understand the background information of patients on elranatamab, early collect data on the safety and efficacy of elranatamab, and take measures necessary for the proper use of elranatamab until the data of a certain number of patients are accumulated.
Interventions
None listed
Sponsors
Pfizer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients who have received at least one dose of elranatamab.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of CRS events in adverse drug reaction | up to 52 weeks | An adverse drug reaction (ADR) in cytokine release syndrome (CRS) was any untoward medical occurrence attributed to Elrexfo in a participant who received this drug. A serious ADR (SADR) was an ADR resulting in any of the following out comes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Relatedness to Elrefxio was assessed by the physician. |
| Incidence of ICANS events in adverse drug reaction | up to 52 weeks | An adverse drug reaction (ADR) in immune effector cell-associated neurotoxicity syndrome (ICANS) was any untoward medical occurrence attributed to Elrexfo in a participant who received this drug. A serious ADR (SADR) was an ADR resulting in any of the following out comes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Relatedness to Elrefxio was assessed by the physician. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients with objective response rate (ORR) | up to 52 weeks | Defined as stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) |
| Incidence of other adverse drug reactions (ADRs) | up to 52 weeks | An adverse drug reaction (ADR) was any untoward medical occurrence attributed to Elrexfo in a participant who received this drug. A serious ADR (SADR) was an ADR resulting in any of the following out comes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Relatedness to Elrefxio was assessed by the physician. |
Countries
Japan
Outcome results
None listed